Endoscopic retrograde cholangiopancreatography (hereinafter “ERCP”) is a common and valuable procedure for patients with a variety of disorders of the pancreas and biliary ducts such as inflammatory strictures, gallstones, leaks, cancer and other abnormalities. In ERCP, a conventional contrast agent (i.e., a dye) is injected into the biliary (also known as bile) and pancreatic ducts using a flexible video endoscope. Then X-rays (e.g., CAT scan) are taken to outline the biliary duct, pancreatic duct and pancreas. However, ERCP is a demanding procedure technically and carries significant risk for the patient. Some of these risks include, for example, pancreatitis or failure to adequately treat the underlying condition. These problems are due in part to the amount of manipulation required to freely canulate the desired target and in part to the pressure resulting from the contrast injection. In many cases, a patient may have a tortuous distal duct with its lumen completely occluded due to collapse of its walls. Currently this is best negotiated with a thin catheter or a slick wire. Repeated attempts at canulation and contrast injection may result in increased pressure, edema and inflammation of the major duodenal papilla (hereinafter “papilla”), causing partial obstruction which can impede canulation further or lead to pancreatitis.
Difficult canulation also can prompt a variety of increasingly aggressive maneuvers such as needle-knife papillotomy that can by themselves add to the risk of the ERCP procedure. Other adverse consequences include tissue infection which may occur when the contrast agent unavoidably dissects into surrounding tissue. Additional adverse consequences include fluorsoscopic exposure and the incorporation of additional “prophylactic” measures such as pancreatic stenting to prevent some of the complications from difficult canulation. Free canulation of the papilla is an essential prerequisite for adequate diagnostic and therapeutic maneuvers related to the procedure of ERCP.
Thus, it would be therefore desirable to offer a solution that would overcome the disadvantages of the procedure described above.